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Post by lakers on Jan 21, 2016 11:51:07 GMT -5
Hakan said they worked w/ some major portfolio management company. Inflamarory disorder means Rheumatoid Arthritis. Neurologic disease means Multiple Sclerosis. 9:01 am Mannkind enters into a collaboration and license agreement with a newly formed entity, Receptor Life Sciences (MNKD) :
The co announced that it has entered into a collaboration and license agreement with a newly formed entity, Receptor Life Sciences, Inc., pursuant to which multiple inhaled therapeutic products will be developed to explore their potential to treat conditions such as chronic pain, neurologic diseases and inflammatory disorders.
Under the terms of the agreement, MannKind will perform initial formulation studies and will work with Receptor to develop inhaled formulations of certain undisclosed compounds. MannKind will also transfer manufacturing technology to the licensee, who will be responsible for manufacturing and commercialization activities. The parties will collaborate on the clinical development of investigational products, with Receptor being responsible for all development costs. MannKind will be eligible to receive development and commercialization milestones of up to $102.25 million as well as mid-single to low double-digit royalties on net sales of product.
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Post by lakers on Jan 21, 2016 2:20:16 GMT -5
Please let me know immediately if Matt responds to any of you. Especially Lakers or Kastanes. That will be a sure sign this company is doomed and I'm going to want to start selling. It was ridiculous enough when Matt was CFO that he didn't have an IR team fielding these sorts of inquiries. If now as CEO he seems to have time to do it, SOS. He may just be a nice guy who wants to be helpful, but that also would be a sure sign this company is doomed. MNKD probably is doomed anyway, but this would be unequivocal evidence. Let's keep a careful eye on this! Believe it or not I never need to correspond to Matt. So one less to worry about. Now there is someone tasked with filtering voice mail for him. You can call, leave a VM, someone else might return your call. He won't respond directly. No use bombarding him. Let him work on dealS. I emphasize plural.
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Post by lakers on Jan 20, 2016 11:51:10 GMT -5
It is easy to say that MNKD should have raised money before, but hindsight is always 20/20. Many on this board were bullish so there is no crime in MNKD being bullish, too. They only had about a month or so with the stock soaring, hardly enough time to get another deal done. Then, the stock started its decline. If they did something at that time, people would have been complaining, too. MNKD had every reason to believe that they would be much better off, but they were wrong. Some on this board are having trouble coming to terms with being wrong, or are poor winners, either way, do what MNKD is doing, keep moving forward. The belief then was that Al had the money, and that is my belief now. It's pretty obvious that Al has the money, but is in no hurry. Why should he be? If that makes some underwater shareholders upset, so be it. Wall St. hates it too because it means THEY are NOT in control, and they hate uncertainty. Therefore, the fiction continues. Obviously you are in the know. I agree with what you said. There are more chapters to this novel. Let's see how events unfold in the next 3 mos. Good day and Good luck!
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Post by lakers on Jan 20, 2016 0:57:09 GMT -5
Hope this isn't off topic but Matt also told us there would be an update or meeting of sorts prior to their earnings CC. So, between our almost announcement at JPM and the fact that we are supposed to get an update prior to CC, Expect news soon. for the love of our portfolios I "hope" it's sooner rather than later. would like to consider having a call with our investors sometime between now and the next earnings call where we can go into a little more detail about some of these things. I hope we'll have a little clearer path we can lay out for some of the initiatives we have going on that we can do after a few days effort in a 25-minute presentation. And maybe I'll even give Ray a few more minutes to talk as well and we'll try to do that sometime between now and our scheduled regular -- we have regularly scheduled earnings call, which is at the end of February. seekingalpha.com/article/3809206-mannkinds-mnkd-ceo-matt-pfeffer-presents-at-34th-annual-jpmorgan-healthcare-conference-transcript?part=singleThus, one might narrow down a little more by deducing that SH meeting might happen after BoD meeting on 2/18/16 and before 2/29/16 ER. It seems BoD might sign off some strategic decisions on 2/18 before Matt and Ray can present to SH.
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Post by lakers on Jan 19, 2016 20:51:00 GMT -5
You said you sold all your Mnkd stocks. Why a concern citizen now ? Did you go long at $1.78 ? What's your investment thesis when you buy back long? It doesn't bother me if you short or buy put either as long as you make money. I simply asked you why the trivia you just posted matters... Why would you care at all if no stake? Other investors deserve to know more. With new lawsuits the company may clamp up. It may not be trivial to others. You can buy US bond if it makes you sleep better.
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Post by lakers on Jan 19, 2016 20:09:33 GMT -5
You said you sold all your Mnkd stocks. Why a concern citizen now ? Did you go long at $1.78 ? What's your investment thesis when you buy back long? It doesn't bother me if you short or buy put either as long as you make money.
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Post by lakers on Jan 19, 2016 19:34:41 GMT -5
When must a company announce earnings? By Investopedia Staff The Securities & Exchange Commission (SEC) requires companies to file earnings reports no later than 45 days after the end of their first three quarters, and their quarterly and annual reports 90 days after their fiscal year end. Companies file quarterly earnings reports on Form 10-Q or 10-QSB and yearly earnings reports on Form 10-K or 10-KSB. A company can file these reports or announce earnings publicly whenever it chooses, provided it follows the 45- and 90-day guidelines set forth by the SEC. However, in an attempt to make information available to the public in a more timely manner, the SEC adopted rules on August 27, 2002, that saw these 45- and 90-day requirements reduced to 35 and 60 days, respectively. The tightening of filing requirements, however, affects only public companies that have a public float of at least $75 million and have been subject to the Securities Exchange Act of 1934 for at least 12 months. The change in time periods was phased in over three years, starting November 15, 2002. For the first year, companies were allowed the 45- and 90-day requirements, then 40- and 75-day requirements the second year, and then 35- and 60-day requirements for the years thereafter. Many websites have the release dates for earnings reports of publicly traded companies. www.investopedia.com/ask/answers/04/050604.asp#ixzz3xjoDX1PT 4Q14 ER was on 2/24/15. Matt said end of Feb 2016 [after BoD meeting on 2/18/16]. For leap year, it's Mon 2/29/16, exactly 60-day limit.
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Post by lakers on Jan 19, 2016 17:24:56 GMT -5
Sue, Thanks for the eloquent response. Inhaled fentanyl in battlefield is priceless compared to morphine needles which may be soiled, less effective, slower acting. Ever seen your comrade suffer in the battlefield or beg for morphine when almost mortally wounded?
There are over 120 international Arm Forces that could use Inhaled fentanyl w/ the right inhaler and carrier. The opp is huge!!
Looking forward to a Veteran Day w/ inhaled fentanyl inhalers displayed alongside.
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Post by lakers on Jan 19, 2016 13:34:43 GMT -5
Matt was announced as CEO as of 11th Jan. So he has been CEO basically for one week. Since he already did the JPM presentation on 13 Jan., it is reasonable that the company does not have or announce any news within a few days of such presentation. It is also expected that Mannkind is all over the place working on executing or fleshing out some of the plans Matt discussed in the JPM presentation. I recall Matt mentioned that he may do a conference call with investors before the next quarterly conference call. I expect the next conference call to be sometime around 10 Feb. Since Matt made the JPM presentation on 13 Jan. and the next quarterly conference will be around 10 Feb., it appears likely that, if Matt does do a conference call before the next quarterly conference, such a call will be scheduled around the end of Jan. My guess is that 29 Jan. (Friday, which is 10 days from today) maybe the date for such a call. If Matt does hold such a call, he may be able to announce a TS deal or other news on such conference call. If not, he will hear some news by the next quarterly conference call (around 10 Feb.), which is three weeks from today. Your timeline is reasonable. The key to unlock SH value is conducting Phase 4 superiority trial yesterday and expediting pediatric study w/ CGM, right dosing at right time. Mnkd can do this while finding the next regional partners so as to not putting all eggs in one basket. The pain Mgmt deal most likely will be Inhaled Fentanyl. After that It will likely be Trespostinil+PDE5 inhibitor for PAH. Mnkd needs to start superiority trial: submit design study, protocol, recruit. The new partner will take it over. Sanofi still bears the cost of Pediatric study until 7/4/16 unless they pay Mnkd a settlement lump sum as Pfizer did to Nektar.
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Post by lakers on Jan 16, 2016 2:23:41 GMT -5
What are the specific challenges for Afrezza on the market? There are several factors that have potentially contributed to its low success thus far, including: Reimbursement for Afrezza has been lacking, which may have made it more costly or inaccessible for patients and harder for doctors to prescribe. Afrezza’s label does not include some of the factors that made it a compelling choice compared to other rapid-acting insulins in clinical trials, including reduced hypoglycemia and “ultra rapid-acting” action. This was really a shame for many, and it also limited what the communication with consumers could look like. Afrezza was launched at the same time as Sanofi’s new basal insulin Toujeo, and it’s possible Toujeo’s launch overshadowed that of Afrezza to a certain extent. We’ve heard that awareness for Afrezza is not high among patients and providers, though it’s not clear if (or to what extent) this directly impacted its sales. We did know a number of doctors, nurses, and patients that had an excellent experience with Afrezza, and we liked the degree to which this was available as an alternative given that so many people are not doing as well as they (or their healthcare teams) would like on traditional “multiple daily injections." New insulins often take time to reach a large audience (even for now-blockbuster insulins like Lantus), and it’s expected that this would be particularly true for a new form of insulin that is inhaled insulin. According to a conversation we had with Sanofi management, nearly two-thirds of Afrezza users who have tried it to date haven’t continued using it after the first-prescription. If that’s true, it’s unclear what exactly is driving the drop-off in use: reimbursement issues? coughing side effects? not enough advantage vs. injectable insulin? The fact that there hasn’t been optimal follow-up is unfortunate, since some of these are addressable. The previous failure of the first inhaled insulin, Exubera, may have negatively influenced perceptions of inhaled insulin in general, especially to healthcare providers. Even Sanofi’s marketing slogan for Afrezza – “Surprise – It’s Inhaled Insulin” – perhaps focused too much on its inhaled design, rather than focusing on what inhaled insulin means for people with diabetes: “No needles!” However, the FDA also regulates direct-to-consumer marketing, so there may have been restrictions in place here. We spoke to diaTribe advisor Dr. Irl Hirsch in December about Afrezza, and he echoed some of these hassles: “In my clinic since Afrezza was launched, out of ten prescribing clinicians … we’ve had three patients try to get the drug, one flunked their pulmonary function test (the mandatory lung-screening test to get Afrezza), two were denied by insurance, and here we are at the end of 2015 and not a single patient of over 3,000 are inhaling their insulin.” In a different world, if endocrinologists had more time and if reimbursement were better, anyone with an A1c over 7% might have been invited to try it. We also point out that in the US, the world has changed – it used to be that doctors and nurses could recommend changes to their patients – or that patients could request certain products. Now, particularly in reimbursement-constrained environments like the Pacific Northwest, the payers are the ones who make the decisions and it’s barely possible for healthcare providers to recommend anything, given the time required and overall difficulty. Still, MannKind is no stranger to challenges. Afrezza was initially rejected by the FDA twice, in 2010 and 2011, before finally receiving approval in 2014. While the road ahead will be challenging, we continue to hear from our readers how for many people, Afrezza has made an incredible impact in their diabetes management. As one patient we spoke to last year told us, “I’ve been impressed at how quickly it works. If I take it at the right time then I can keep my blood sugars at a pretty normal range. My goal with Afrezza is to maintain an A1c that is a normal person’s A1c and it looks like I may be able to do that.” We hope MannKind will find a way to bring this insulin to more people with diabetes – the faster action, lower rate of hypoglycemia, and absence of needles are advantages that could benefit many people. –AB/AJW/KC - See more at: diatribe.org/sanofi-terminates-partnership-mannkinds-inhaled-insulin-afrezza?platform=hootsuite#sthash.8WdYLzSj.dpuf
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Post by lakers on Jan 15, 2016 20:45:45 GMT -5
Will know in a few weeks. This may lead to the same regional partner for Afrezza according to MNholdem as I vaguely remember. You can ask him.
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Post by lakers on Jan 15, 2016 20:07:03 GMT -5
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Post by lakers on Jan 15, 2016 19:43:01 GMT -5
Disclosed Pipeline: Primatene ® files.shareholder.com/downloads/AMDA-2XT20G/1352170617x0x863871/2BB3AAD0-2F69-4FDB-A0C8-ABC968822E83/Amphastar_IR_27th_Annual_Piper_Jaffray_Healthcare_Conference_2015-12-01.pdf [This drug doesn't use TS particle] Slide 16 ■ Primatene ®, a proprietary and patent protected over-the-counter epinephrine
inhalation product candidate, is intended for the temporary relief of mild
symptoms of intermittent asthma■ Acquired the trade name, Primatene ® Mist, in 2008 ■ Company reformulated Primatene ® using HFA as a propellant and submitted an NDA in 2013 ■ In February 2014, the FDA’s advisory committee voted that data supported efficacy, but that safety had not been established for OTC use ■ Received complete response letter from the FDA in May 2014, which asked for additional data, label revisions and follow-up studies to support consumers’ ability to correctly use the product in the OTC setting ■ The Company conducted label comprehension studies and is currently performing, behavioral studies ■ The Company met with the FDA in October 2014 ■ The Company anticipates re-filing the NDA 2016Slide 6 ■ Armstrong: Canton, MA, 251,750 square feet ■ Currently being qualified to manufacture inhalation products ■ Site for developing pipeline of MDI products ■ Future site of Primatene® HFA
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Post by lakers on Jan 15, 2016 19:30:46 GMT -5
Meet Inhaled Fentanyl. Competitor: AeroLEF, TAIFUN books.google.com/books?id=ZwPIjKg0XukC&pg=PA444&lpg=PA444&dq=inhaled+fentanyl+as+a+method+of+pain&source=bl&ots=J8gQhf6IjT&sig=kAJ9777_Xb9iyJl5kubB3mTxJ4g&hl=en&sa=X&ved=0ahUKEwjY---dgK3KAhUO42MKHYXYA24Q6AEIUTAH#v=onepage&q=inhaled%20fentanyl%20as%20a%20method%20of%20pain&f=falsewww.oindpnews.com/2011/08/akela-discontinues-inhaled-fentanyl-development-program/Akela discontinues inhaled fentanyl development program Akela Pharma is looking for a buyer for its Taifun fentanyl development program after Teikoku Seiyaku returned Japanese rights to the product. The dry powder inhaler (DPI) was being developed for the treatment of breakthrough pain in cancer patients. Akela is also in negotiations with another development partner, Janssen Pharmaceutica, for the return of the remaining rights. As a result of the discontinuation of the program, Akela says, it is also filing for bankruptcy of its Finnish subsidiary, Akela Pharma, Oy. The company says that it will now focus its attention on its PharmaForm CRO, which provides contract solid dose formulation and clinical supply manufacturing services. “The discontinuation of the Fentanyl TAIFUN program enables Akela to fully deploy its management and capital resources on the profitable PharmaForm subsidiary which is a logical transformation following our successful turnaround of Akela over the past 24 months,” explained Akela President and CEO Greg McKee. “Given the market capitalization of the Company, our proven track record of dramatically increasing profitability while growing revenues, coupled with a targeted acquisition strategy, we believe that our contract manufacturing platform has the ability to enhance shareholder value without the capital requirements and risks associated with traditional drug development companies.” www.oindpnews.com/2014/01/how-an-abandoned-inhaler-project-led-to-a-cdmo-makeover/How an abandoned inhaler project led to a CDMO makeover CDMO PharmaForm was reborn as Formex in 2013 A new, or at least new-ish, contract development and manufacturing company called Formex LLC launched on March 8, 2013 after its parent company, Biotech Investment Group (B.I.G.), acquired all of the assets formerly belonging to Akela Pharma subsidiary PharmForm. Formex’s services are the same as PharmaForm’s, including formulation development and GMP clinical manufacturing for various dosage forms, including intranasal and dry powder inhalation products. In 2012, B.I.G. Chairman Masood Tayebi saw an opportunity when PharmaForm approached the company about renting space in its 80,000 sq. ft. facility in Torrey Pines, which had been built originally for Biogen Idec. Tayebi was looking to partner with a formulation company to complement his existing drug discovery businesses, and PharmaForm was looking to move to California from Texas at the request of clients. Finding a manufacturing facility built to GMP standards would make the transition as smooth as possible, and in October 2012, PharmaForm announced that it would move into the Torrey Pines Facility. Soon, though, it became apparent that Akela was in trouble, the result, former Akela President and CEO Rudy Emmelot says, of debts related to the company’s discontinued Taifun inhaled fentanyl development program. When the Akela stopped development on the Taifun inhaler, then-President and CEO Greg McKee asserted that the discontinuation would allow the company “to fully deploy its management and capital resources on the profitable PharmaForm subsidiary.” The Taifun inhaler In December of 2012, however, Akela voluntarily delisted from the Toronto Stock Exchange, stating that “doubt remains regarding the Corporation’s ability to continue as a going concern.” Soon after, Akela signed the lease with B.I.G., and two months later, Akela announced that it was in default on the lease and that B.I.G. had foreclosed, acquiring all of its assets. On March 11, 2013 Emmelot and all of Akela’s other board members resigned, marking the official end of that company and the beginning of Formex. Emmelot became the President and CEO of Formex, and the new company offered positions to most of PharmaForm’s employees. Formex began operations in the facilities immediately. “There was complete continuity with no business interruption,” Emmelot says: “The one thing all along that PharmaForm, and now Formex, has wanted to ensure is that the transition had no impact on our clients.” Akela had struggled with the Taifun inhaler program for almost a decade before giving up. The inhaled fentanyl product was originally developed in the late 1990s by Finnish pharmaceutical company Leiras. In 2003, when Akela was still known as LAB International, it acquired the inhaler by purchasing a Leiras spin-off called Focus Inhalation. Akela began work to develop the product as a treatment for breakthrough pain in cancer patients.
“Inhalation has been an inherently risky place to be operating in because of the inherent risks of the dosing mechanisms,” notes Emmelot, and since fentanyl is an opiate that is significantly more potent than morphine, questions arose related to the safety of residual amounts of fentanyl left in the inhaler. Those questions led the company to reevaluate the Taifun device’s design.
The Taifun device was a reservoir-type DPI, which meant that fentanyl would always remain inside for dosing reasons. Even if the multi-dose inhaler could be converted to single-dose, as the company contemplated, a certain amount of fentanyl would still be retained after use due to static. Regulators would naturally have concerns about the use and disposal of such a device, Emmelot acknowledges. When a European trial of the product ended in 2008 after dosing of the 13th patient, he says, the project was halted.
Masood Tayebi and Rudy Emmelot According to Emmelot, Akela investigated the possibility of a second generation device that would take various issues into account, including child safety locks, disposal, and the potential for abuse. Its partners in the Taifun fentanyl project, Takeda and Janssen Pharmaceutica, however, questioned the economic viability of a redesign, especially given problems with other inhaler projects at the time, including the failure of Exubera inhaled insulin.
In 2011, the two companies decided to stop development of the product and return the rights to Akela. Akela hired consultants to help find new partners for the inhaled fentanyl project, Emmelot says, but “no one was interested in picking it up.” With no takers for the IP, most of the patents will eventually lapse. Now, Emmelot says, B.I.G.’s resources will allow the company “to increase its capabilities, taking our clients further down the development pipeline,” so that “our clients can transfer when they want to transfer and not be limited by our capacity for advancing the manufacturing process.” In addition to the financial resources necessary to stabilize the company, Tayebi also brings extensive experience with life sciences, having founded BioDuro, a drug discovery CRO he later sold to PPD. According to Tayebi, he plans to turn Formex into a full service CDMO, adding commercial manufacturing to the company’s capabilities. As part of that process, he hopes to double the size of the staff up to about 75-80 employees by the end of 2014, and he says that he plans to maintain Formex’s inhalation capabilities is part of his strategy to differentiate Formex from other CDMOs.
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Post by lakers on Jan 15, 2016 15:00:19 GMT -5
Genzymes contract had more favorable wording for their lawsuit than does Mannkinds contract for a similar suit (i would think and leave it up to lawyers here for their opinions). Mannkind contract said "reasonable" efforts Genzyme contract with Sanofi had "diligent" efforts. Sanofi's effort was far from Commercially Reasonable due to Conflict of Interest. Their effort was more like sandbagging effort. The lawyer and jury just need to compare it to Pfizer's effort on Exubera, and Sanofi's effort on Toujeo, Apidra, Lantus. Mnkd has a very strong case w/ ample evidence here, good leverage for large settlement or a full blown muti-billion suit.
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